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| ID | Type | Description | Link |
|---|---|---|---|
| IND 157468 | Other Identifier | U.S. Food and Drug Administration | |
| R01HL142297 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.
The objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single 68Ga-Galmydar injection in normal healthy volunteers. Healthy adult normal volunteers (n=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group).
Healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous Ga-68 Galmydar administration of 8 mCi ± 20% (6.4-9.6 mCi) with a mass of ≤ 10 µg followed by whole-body PET/CT imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosimetry Group | Experimental | Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post [68Ga]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 Galmydar | Drug | Single intravenous injection of the PET radiotracer 68Ga-Galmydar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Organ Dosimetry | On whole body PET/CT, regions of interest are drawn on the liver, spleen, kidney, lumbar vertebrae and left ventricle of the heart. Average organ dose is measured and compared. Organ radiation dose is measured and reported in rad/mCi. | 6 hours from 68Ga-Galmydar injection |
| Biodistribution | The organ with the highest radiation dose in rad/mCi is determined to be the dose-critical organ. The organ showing the largest dose is the gallbladder wall. | 6 hours from 68Ga-Galmydar injection |
| Total Effective Dose of the Radiotracer | Total Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi. | 6 hours from 68Ga-Galmydar injection |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Significant Change in Blood Pressure. | The following variables are considered clinically significant if changes occur from baseline. A systolic BP of < 90 or > 160 mmHg or a diastolic BP of < 50 or > 100 mmHg or a 20 mmHg change from baseline in the SBP or DBP. | 6 hours from 68Ga-Galmydar injection |
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Inclusion Criteria:
• Healthy men and women, 18-99 years of age and any race
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela K Woodard, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29454148 | Background | Sivapackiam J, Laforest R, Sharma V. 68Ga[Ga]-Galmydar: Biodistribution and radiation dosimetry studies in rodents. Nucl Med Biol. 2018 Apr;59:29-35. doi: 10.1016/j.nucmedbio.2017.11.008. Epub 2017 Dec 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dosimetry Group | Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post [68Ga]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations. Ga-68 Galmydar: Single intravenous injection of the PET radiotracer 68Ga-Galmydar. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dosimetry Group | Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post [68Ga]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations. Ga-68 Galmydar: Single intravenous injection of the PET radiotracer 68Ga-Galmydar. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Organ Dosimetry | On whole body PET/CT, regions of interest are drawn on the liver, spleen, kidney, lumbar vertebrae and left ventricle of the heart. Average organ dose is measured and compared. Organ radiation dose is measured and reported in rad/mCi. | Posted | Mean | Standard Deviation | rad/mCi | 6 hours from 68Ga-Galmydar injection |
|
14 days after participant received injection of radiotracer
Study staff contacted participants by phone following the administration of [68Ga]Galmydar to confirm the subject's well-being and to ascertain if an adverse event occurred post-imaging procedures. Subjects received a phone call within 2-3 days and at 5-7 days or as late as 14 days post [68Ga]Galmydar injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dosimetry Group | Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post [68Ga]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations. Ga-68 Galmydar: Single intravenous injection of the PET radiotracer 68Ga-Galmydar. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela K. Woodard | Washington University School of Medicine | 314-362-7100 | woodardp@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2022 | Aug 3, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 25, 2022 | Aug 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Clinically Significant Change in Heart Rate. |
A heart rate of < 50 BPM or > 100 or a 20 BPM change from baseline. |
| 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Respiratory Rate. | A respiratory rate of < 12 or > 20 breaths/min. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Elevation in Oral Temperature | Oral temperature of >100 degrees F. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in EKG Showing New AV Block | A change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms). | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in EKG Showing New Bradycardia | New heart rate < 40 BPM. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Serum chemistries (sodium, potassium, chloride, CO2) measured in mmol/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Serum chemistries (glucose, calcium creatinine, BUN, total bilirubin), measured in mg/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in White Blood Cell Count (WBC) | White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Hemoglobin (Hgb) | Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Hematocrit (Hct) | Hct measured in %. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Platelets | Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Red Blood Cell Count (RBC) | RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Clinically Significant Change in Mean Corpuscular Volume (MCV) | MCV measured in µm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
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|
| Primary | Biodistribution | The organ with the highest radiation dose in rad/mCi is determined to be the dose-critical organ. The organ showing the largest dose is the gallbladder wall. | Posted | Mean | Standard Deviation | rad/mCi | 6 hours from 68Ga-Galmydar injection |
|
|
|
| Primary | Total Effective Dose of the Radiotracer | Total Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi. | Posted | Mean | Standard Deviation | rem/mCi | 6 hours from 68Ga-Galmydar injection |
|
|
|
| Secondary | Clinically Significant Change in Blood Pressure. | The following variables are considered clinically significant if changes occur from baseline. A systolic BP of < 90 or > 160 mmHg or a diastolic BP of < 50 or > 100 mmHg or a 20 mmHg change from baseline in the SBP or DBP. | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
|
|
|
| Secondary | Clinically Significant Change in Heart Rate. | A heart rate of < 50 BPM or > 100 or a 20 BPM change from baseline. | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
|
|
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| Secondary | Clinically Significant Change in Respiratory Rate. | A respiratory rate of < 12 or > 20 breaths/min. | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
|
|
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| Secondary | Clinically Significant Elevation in Oral Temperature | Oral temperature of >100 degrees F. | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
|
|
|
| Secondary | Clinically Significant Change in EKG Showing New AV Block | A change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
|
|
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| Secondary | Clinically Significant Change in EKG Showing New Bradycardia | New heart rate < 40 BPM. | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
|
|
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| Secondary | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Serum chemistries (sodium, potassium, chloride, CO2) measured in mmol/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo serum chemistries. Three patients did not undergo post-injection serum chemistries due to various issues (IV, blood hemolysis, or wrong labs). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
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| Secondary | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Serum chemistries (glucose, calcium creatinine, BUN, total bilirubin), measured in mg/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo serum chemistries. Three patients did not undergo post-injection serum chemistries due to various issues (IV, blood hemolysis, or wrong labs). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
|
|
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| Secondary | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo serum chemistries. Three patients did not undergo post-injection serum chemistries due to various issues (IV, blood hemolysis, or wrong labs). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
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| Secondary | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo serum chemistries. Three patients did not undergo post-injection serum chemistries due to various issues (IV, blood hemolysis, or wrong labs). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
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| Secondary | Clinically Significant Change in White Blood Cell Count (WBC) | White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
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| Secondary | Clinically Significant Change in Hemoglobin (Hgb) | Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
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| Secondary | Clinically Significant Change in Hematocrit (Hct) | Hct measured in %. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
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| Secondary | Clinically Significant Change in Platelets | Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
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| Secondary | Clinically Significant Change in Red Blood Cell Count (RBC) | RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
|
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| Secondary | Clinically Significant Change in Mean Corpuscular Volume (MCV) | MCV measured in µm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis). | Posted | Count of Participants | Participants | 6 hours from 68Ga-Galmydar injection |
|
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|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Abnormal |
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| Baseline Diastolic Blood Pressure |
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| Post-Injection Diastolic Blood Pressure |
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| Equivalence |
A McNemar test was performed between baseline and post-injection Diastolic Blood Pressure values. The values were categorized as Normal or Abnormal. |
The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Diastolic Blood Pressure values were normal. |
| Abnormal |
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| Abnormal |
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| Abnormal |
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| Abnormal |
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| Abnormal |
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| Post-Injection Sodium |
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| Baseline Potassium |
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| Post-Injection Potassium |
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| Baseline Chloride |
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| Post-Injection Chloride |
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| Baseline CO2 |
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| Post-Injection CO2 |
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| Equivalence |
A McNemar test was performed between baseline and post-injection Potassium values. The values were categorized as Normal or Abnormal. |
The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Potassium values were normal. |
| Equivalence | A McNemar test was performed between baseline and post-injection Chloride values. The values were categorized as Normal or Abnormal. | The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Chloride values were normal. |
| McNemar | 0.219 | The threshold for statistical significance was p = 0.05. | Equivalence | A McNemar test was performed between baseline and post-injection CO2 values. The values were categorized as Normal or Abnormal. |
| Post-Injection Glucose |
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| Baseline Calcium |
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| Post-Injection Calcium |
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| Baseline Creatinine |
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| Post-Injection Creatinine |
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| Baseline BUN |
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| Post-Injection BUN |
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| Baseline Total Bilirubin |
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| Post-Injection Total Bilirubin |
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| 0.375 |
The threshold for statistical significance was p = 0.05. |
| Equivalence |
A McNemar test was performed between baseline and post-injection Calcium values. The values were categorized as Normal or Abnormal. |
| McNemar | 0.453 | The threshold for statistical significance was p = 0.05. | Equivalence | A McNemar test was performed between baseline and post-injection Creatinine values. The values were categorized as Normal or Abnormal. |
| McNemar | 0.125 | The threshold for statistical significance was p = 0.05. | Equivalence | A McNemar test was performed between baseline and post-injection BUN values. The values were categorized as Normal or Abnormal. |
| McNemar | 0.219 | The threshold for statistical significance was p = 0.05. | Equivalence | A McNemar test was performed between baseline and post-injection Total Bilirubin values. The values were categorized as Normal or Abnormal. |
| Post-Injection Total Protein |
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| Baseline Albumin |
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| Post-Injection Albumin |
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| McNemar |
| 0.219 |
The threshold for statistical significance was p = 0.05. |
| Equivalence |
A McNemar test was performed between baseline and post-injection Albumin values. The values were categorized as Normal or Abnormal. |
| Post-Injection Alkaline Phosphatase |
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| Baseline ALT |
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| Post-Injection ALT |
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| Baseline AST |
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| Post-Injection AST |
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| McNemar |
| 0.219 |
The threshold for statistical significance was p = 0.05. |
| Equivalence |
A McNemar test was performed between baseline and post-injection ALT values. The values were categorized as Normal or Abnormal. |
| Equivalence | A McNemar test was performed between baseline and post-injection AST values. The values were categorized as Normal or Abnormal. | The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the AST values were normal. |
| Post-Injection WBC |
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| Post-Injection Hemoglobin |
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| Post-Injection Hematocrit |
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| Post-Injection Platelets |
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| Post-Injection RBC |
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| Post-Injection MCV |
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